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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: N-acetyl-procainamide
Date Designated: 12/10/1996
Orphan Designation: Prevention of life-threatening ventricular arrhythmias in patients with documented procainamide-induced lupus.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
NAPA of the Bahamas
3560 Pennsylvania Avenue, Suite 7
Dubuque, Iowa 52002
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.